Drug developers and others with a stake in bringing new drugs and biologics to market will have a chance today to sound off on a fifth authorization of the Prescription Drug User Fee Act ( PDUFA V) when FDA holds a day-long public hearing on the topic. Their comments are expected to shape FDA’s final recommendation on PDUFA V, which the agency will send to Congress in January 2012.
The companies aren’t expected to disagree too much with the framework hammered out earlier this year by FDA and the two groups that represent drug developers, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
Perhaps the most important change, as noted on the Proposed PDUFA V Reauthorization Performance Goals and Procedures for Fiscal Years 2013 through 2017, is that drug industry groups and FDA agreed that companies seeking approval for new drugs and biologics, as well as new indications for drugs already on the market, must communicate more with the agency than required under the current PDUFA IV, which expires at the end of September 2012.
According to the Draft Commitment Letter signed by FDA, BIO, and PhRMA, PDUFA V pushes back the start of FDA’s clock for its first review cycle to after its 60-day administrative filing review period. Once the clock starts, however, FDA is committed to reviewing and acting on 90% of standard New Molecular Entity (NME), New Drug Application (NDA), and original Biologics License Applications (BLA) submissions within 10 months—12 months from the date of filing—and on 90% of priority NME, NDA, and original BLA submissions within six months, or eight months from date of filing.
Once the PDUFA V review clock starts running, drug developers and FDA officials must meet three times:
- A presubmission meeting at which “the applicant is strongly encouraged to discuss the planned content of the application.”
- A new mid-cycle meeting to which FDA will call an applicant, generally within two weeks after the agency holds its own internal mid-cycle review meeting on an application.
- A late-cycle meeting at which FDA’s review team will meet with an applicant to discuss the status of agency review of the application late in the review cycle.
“What the industry wants to avoid is this syndrome: you submit your application and you suffer this radio silence,” Nancy Bradish Myers, president/founder of Catalyst Healthcare Consulting, told GEN. “One of the things the regulatory people in the companies are really clamoring for is predictability. I think this series of meetings will really help the people who are running the actual submission understand where the agency is in reviewing their submission. It is very important.”
What regulatory executives within drug developers also want, Myers said, is the opportunity to address FDA concerns as soon as they arise, rather than be lulled into thinking all is well, only to be jolted by a complete response letter (CRL) detailing issues that had not come up before.